Hemodialysis ComplicationNCT05872984
Evaluation of Total Blood Volume Measurement During Dialysis on the Incidence of Intradialytic Hypotension
A study testing adjustment of dry weight based on absolute blood volume measurement in people with Hemodialysis Complication and Hypotension During Dialysis, run by HagaZiekenhuis at 1 site in Netherlands.
Trial summary
Establishing the euvolemic state in hemodialysis patients -the so called "dry weight"- is an important clinical conundrum in every nephrologist's daily practice. Underestimation of dry weight (with excessive ultrafiltration) results in dialysis-induced hypotension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication, Hypotension During Dialysis, Diagnostic Tests
- What is being tested?
- adjustment of dry weight based on absolute blood volume measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Jul 2020to 17 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemodialysis patients of three dialysis locations of the Haga Hospital (Zoetermeer, The Hague Leyweg and The Hague Sportlaan).
- Maintenance hemodialysis, with initiation of treatment predates inclusion in the study by at least 3 months.
- Hemodialysis scheme three times weekly for four hours
- Age above 18 years.
Who cannot join
- Clinically relevant fistula dysfunction resulting in single poold Kt/V <1,2
- Severe volume overload with a contraindication to bolus fluid infusion during dialysis according to the treating physician.
- Severe cardiac dysfunction responsible for >1x intradialytic hypotension associated adverse event /week according to treating physician
- Severe liver failure with or without presence of ascites
- More than three hemodialysis sessions per week
- Single needle treatment
Show all 9Show fewer
- Central venous access
- Residual diuresis > 500 ml/ 24h
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of the Influence of the Use of Total Blood Volume Measurement During Dialysis on the Incidence of Intradialytic Hypotension Associated Events
Establishing the euvolemic state in hemodialysis patients -the so called "dry weight"- is an important clinical conundrum in every nephrologist's daily practice. Underestimation of dry weight (with excessive ultrafiltration) results in dialysis-induced hypotension. Currently used methods to establish dry weight, including clinical assessment, bio-impedance spectroscopy and online relative blood volume (RBV) measurements, all have their limitations. RBV measurement reflects changes in blood volume during dialysis without providing any information about the initial hydration status, or the initial absolute blood volume (ABV). Recently, researchers proposed a new method to calculate ABV, by using the principle of dilution-indicator with RBV measurement. In a small cohort study they identified a total blood volume threshold of 65 millilitres per kilogram dry weight predicting for intra-dialytic hypotension associated symptoms.
The goal of current clinical trial is to re-investigate the accuracy of the above-described method and to confirm the hypothesis of a critical threshold of 65 ml blood volume per kg dry weight in haemodialysis patients. Researchers will compare adjustment of dry weight based on the ABV measurement with standard care to see if dialysis-induced hypotension will be reduced.
- Being tested
- adjustment of dry weight based on absolute blood volume measurement
- Keywords
- Hemodialysis, Intradialytic hypotension, Intradialytic morbid events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjustment of dry weight based on absolute blood volume measurementDiagnostic test
adjustment of dry weight based on absolute blood volume measurement
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm: adjustment of dry weight based on absolute blood volume measurement | Experimental | Dry weight will be adjusted at the start of the intervention period in all subjects in the intervention group with a normalized blood volume below 65 ml/kg, regardless the occurrence of intradialytic hypotension associated adverse events during the baseline period. Dry weight will be adjusted once with 0,5kg. Receives: Diagnostic Test: adjustment of dry weight based on absolute blood volume measurement |
| Control arm: standard care | No intervention | standard care provided by the clinician, no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in the incidence of intradialytic hypotension-associated adverse events between the intervention and control group
The incidence of intradialytic hypotension-associated adverse events (IHAAE) will be compared at baseline and after intervention, using questionnaires. Participants will undergo a 4-week run-in period to assess baseline incidence. The incidence of IHAAE will be calculated by dividing the number of dialysis treatments with one or more symptoms attributable to IHAAE as a percentage of the total number of dialysis treatments with a completed questionnaire.
After randomization and the intervention, the occurence of IHAAE will be measured in both arms for another four weeks.
Differences in incidence of IHAAE between groups will be analyzed using ANCOVA, adjusting for baseline IHAAE, pre-dialysis blood pressure and the use of anti-hypertensive agents.
IHAAE is defined as a systolic blood pressure < 90 mmHg Either symptomatic or asymptomatic, or solely symptoms associated to (impeding) hypotension like dizziness, lightheadedness, sweating, cramps or visuel disturbances.
Measured: 10 weeks
Secondary outcomes (5)
Baseline incidence of intradialytic hypotension associated adverse events (IHAAE) in the entire study population.
Eligible participants will undergo a 4-week run-in period to assess baseline incidence of IHAAE, using questionnaires.
The incidence of IHAAE will be calculated by dividing the number of dialysis treatments with one or more symptoms attributable to IHAAE as a percentage of by the total number of dialysis treatments with a completed questionnaire.
Measured: baseline
Reproducibility of absolute blood volume measurement
Absolute blood volume (ABV) will be measured twice in the entire study population, at the start of two mid-weekly hemodialysis treatments.
We will investigate the correlation between these two test results, using Bland Altman Analysis.
Measured: 2 weeks
Correlation of absolute blood volume measurement with other diagnostic tests to determine blood volume
We will calculate antropomorphic blood volume in the whole study population, using the Nadler's formula.
We will randomly select 10 participants for ABV measurement with the reference method.This technique is based on the isotope-dilution principal using I-251 radiolabeled human serum albumin. Adverse events due to the infusion of radioactive labelled albumin are very rare (0.01-0.1%, <0.01 % anaphylactic reactions). For a 70kg-patient the dose will be 0,02 millisievert. This falls within risk category I according to the International Commission on Radiological Protection (ICRP). This is the lowest risk category with a statistical probability of less than five in a million to develop radiation induced cancer. Annual background radiation level in the Netherlands is about 2,5 mSv.
We will correlate the results of these diagnostic tests to our ABV measurement, using Bland Altman analysis.
Measured: 2 weeks
Sensitivity, specificity
We will use the values of absolute volume measurement and incidence of IHAAE to calculate sensitivity, specificity of the previously defined critical threshold of normalized blood volume of 65 ml/kg for the occurrence of IHAAE.
Measured: 10 weeks
positive predictive value, negative predictive value
We will use the values of absolute volume measurement and incidence of IHAAE to calculate positive and negative predictive value of the previously defined critical threshold of normalized blood volume of 65 ml/kg for the occurrence of IHAAE.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start9 Jul 2020
- Primary completion31 May 2021
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention consists of the adjustment of the patients' dry weight, based on absolute blood volume measurement. Dry weight will be adjusted at the start of the intervention period in all subjects in the intervention group with a normalized blood volume below 65 ml/kg, regardless the occurrence of intradialytic hypotension associated adverse events during the baseline period. Dry weight will be increased once with 0,5kg.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- HagaZiekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Jean Vleming, HagaZiekenhuis
- Investigators
- Louis Jean Vleming, dr, Principal investigator, HagaZiekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872984
- Sponsor's protocol ID
- NL71892.058.19
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Influence of the Use of Total Blood Volume Measurement During Dialysis on the Incidence of Intradialytic Hypotension Associated Events
- ClinicalTrials.gov ID
- NCT05872984
- Acronym / sponsor ID
- NL71892.058.19
- Keywords
- Hemodialysis, Intradialytic hypotension, Intradialytic morbid events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- HagaZiekenhuisUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Establishing the euvolemic state in hemodialysis patients -the so called "dry weight"- is an important clinical conundrum in every nephrologist's daily practice. Underestimation of dry weight (with excessive ultrafiltration) results in dialysis-induced hypotension. Currently used methods to establish dry weight, including clinical assessment, bio-impedance spectroscopy and online relative blood volume (RBV) measurements, all have their limitations. RBV measurement reflects changes in blood volume during dialysis without providing any information about the initial hydration status, or the initial absolute blood volume (ABV). Recently, researchers proposed a new method to calculate ABV, by using the principle of dilution-indicator with RBV measurement. In a small cohort study they identified a total blood volume threshold of 65 millilitres per kilogram dry weight predicting for intra-dialytic hypotension associated symptoms.
The goal of current clinical trial is to re-investigate the accuracy of the above-described method and to confirm the hypothesis of a critical threshold of 65 ml blood volume per kg dry weight in haemodialysis patients. Researchers will compare adjustment of dry weight based on the ABV measurement with standard care to see if dialysis-induced hypotension will be reduced.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention consists of the adjustment of the patients' dry weight, based on absolute blood volume measurement. Dry weight will be adjusted at the start of the intervention period in all subjects in the intervention group with a normalized blood volume below 65 ml/kg, regardless the occurrence of intradialytic hypotension associated adverse events during the baseline period. Dry weight will be increased once with 0,5kg.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm: adjustment of dry weight based on absolute blood volume measurement | Experimental | Diagnostic Test: adjustment of dry weight based on absolute blood volume measurementDry weight will be adjusted at the start of the intervention period in all subjects in the intervention group with a normalized blood volume below 65 ml/kg, regardless the occurrence of intradialytic hypotension associated adverse events during the baseline period. Dry weight will be adjusted once with 0,5kg. |
| Control arm: standard care | No intervention | –standard care provided by the clinician, no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hemodialysis patients of three dialysis locations of the Haga Hospital (Zoetermeer, The Hague Leyweg and The Hague Sportlaan).
- Maintenance hemodialysis, with initiation of treatment predates inclusion in the study by at least 3 months.
- Hemodialysis scheme three times weekly for four hours
- Age above 18 years.
Key exclusion criteria (9 listed)
- Clinically relevant fistula dysfunction resulting in single poold Kt/V <1,2
- Severe volume overload with a contraindication to bolus fluid infusion during dialysis according to the treating physician.
- Severe cardiac dysfunction responsible for >1x intradialytic hypotension associated adverse event /week according to treating physician
- Severe liver failure with or without presence of ascites
- More than three hemodialysis sessions per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adjustment of dry weight based on absolute blood volume measurementadjustment of dry weight based on absolute blood volume measurement | Diagnostic test | Intervention arm: adjustment of dry weight based on absolute blood volume measurement |
Primary outcome
difference in the incidence of intradialytic hypotension-associated adverse events between the intervention and control group
Time frame: 10 weeks
The incidence of intradialytic hypotension-associated adverse events (IHAAE) will be compared at baseline and after intervention, using questionnaires. Participants will undergo a 4-week run-in period to assess baseline incidence. The incidence of IHAAE will be calculated by dividing the number of dialysis treatments with one or more symptoms attributable to IHAAE as a percentage of the total number of dialysis treatments with a completed questionnaire. After randomization and the intervention, the occurence of IHAAE will be measured in both arms for another four weeks. Differences in incidence of IHAAE between groups will be analyzed using ANCOVA, adjusting for baseline IHAAE, pre-dialysis blood pressure and the use of anti-hypertensive agents. IHAAE is defined as a systolic blood pressure < 90 mmHg Either symptomatic or asymptomatic, or solely symptoms associated to (impeding) hypotension like dizziness, lightheadedness, sweating, cramps or visuel disturbances.
5 secondary outcomes
Baseline incidence of intradialytic hypotension associated adverse events (IHAAE) in the entire study population.
Time frame: baseline
Reproducibility of absolute blood volume measurement
Time frame: 2 weeks
Correlation of absolute blood volume measurement with other diagnostic tests to determine blood volume
Time frame: 2 weeks
Sensitivity, specificity
Time frame: 10 weeks
positive predictive value, negative predictive value
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Jean Vleming, dr principal investigator
HagaZiekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adjustment of dry weight based on absolute blood volume measurement in people with Hemodialysis Complication and Hypotension During Dialysis, run by HagaZiekenhuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in the incidence of intradialytic hypotension-associated adverse events between the intervention and control group (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.